Image IV DICOM Image Archival PACS Network

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K010058 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Calysto Series IV Patient Care Monitors and Central Station and ECG Management System

  Class II

  FDA 510(k) K033030 Active Cleared 24 Feb 2004

• Witt Biomedical Series II-Ep

  Class II

  FDA 510(k) K923054 Active Cleared 25 Feb 1993

• Calysto Series IV Physio-Monitoring and Information System

  Class II

  FDA 510(k) K063547 Active Cleared 21 Dec 2006

• Witt Biomedical Vx-80

  Class II

  FDA 510(k) K880258 Active Cleared 16 Jun 1988

• Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units

  Class II

  FDA 510(k) K973474 Active Cleared 13 Mar 1998

• Witt Biomedical Image III

  Class II

  FDA 510(k) K945582 Active Cleared 19 Jun 1995

See all devices from Witt Biomedical Corp →

• What is the Image IV DICOM Image Archival PACS Network used for?

  The Image IV DICOM Image Archival PACS Network is designed for the storage, retrieval, and management of DICOM medical images within a radiology environment. It functions as a networked archival solution that integrates with imaging modalities and PACS infrastructure to support the handling of diagnostic images, enabling efficient workflow in radiology settings.

• How is the Image IV DICOM Image Archival PACS Network supplied and intended for use?

  The device is supplied as a reusable system intended for use in radiology settings. It is not a single-use product but rather a networked archival solution designed for ongoing operation within medical imaging facilities, requiring appropriate storage conditions and standard environmental and electrical specifications for medical imaging equipment.

• What regulatory pathway was used for the Image IV DICOM Image Archival PACS Network?

  The Image IV DICOM Image Archival PACS Network was cleared by the FDA through the 510(k) process under K010058 on March 21, 2001. It is classified as a Class II device under product code LLZ, with a traditional clearance type and a substantially equivalent decision based on the statement summary provided in the submission.